GSK Submits IMPACT Data To EU To Support Trelegy Ellipta's Expanded Labelling

(RTTNews) - GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) Wednesday announced the submission of the IMPACT data to the European Medicines Agency as part of a type II variation to support an expanded label for Trelegy Ellipta in Europe. This submission will be in support for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease or COPD.

The regulatory submission is primarily based on data from the IMPACT study showing Trelegy Ellipta was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist, Relvar/Breo, and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist, Anoro, on a range of clinically important endpoints. The study has found that Trelegy Ellipta reduced the number of exacerbations or 'flare ups' patients experienced, and improved lung function and health related quality of life.

Glaxo said the supplemental New Drug Application to the US Food and Drug Administration is currently under review.

Dr. Theodore J. Witek Jr., Senior Vice President and Chief Scientific Officer of Innoviva added, "The data included in this submission build on existing evidence supporting the role of once-daily single inhaler triple therapy in the treatment of appropriate patients with COPD. If approved, updates to the Trelegy Ellipta labelling will give clinicians additional information to help guide their treatment choices."

IMPACT is the first study to directly compare three commonly used COPD combination treatment classes delivered using the same dose and inhaler.